New Use of Dabigatran or Warfarin and Gastrointestinal Hemorrhage or Intracerebral Hemorrhage Events

    Basic Details
    Date Posted
    Tuesday, June 21, 2016
    Status
    Complete
    Medical Product
    dabigatran
    warfarin
    Health Outcome(s)
    gastrointestinal hemorrhage
    intracerebral hemorrhage (ICH)
    Description

    Modular program-based one-time assessment of gastrointestinal hemorrhage (GIH) or intracerebral hemorrhage (ICH) events following new use of dabigatran or warfarin among all patients with and without a pre-existing condition of atrial fibrillation. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of October 19, 2010 to June 30, 2013.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 1.0; click here for more information.  Queries were distributed in June 2014. This report includes data from 15 Data Partners.
     
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    Additional Details
    FDA Center
    CDER
    Time Period
    October 19, 2010 - June 30, 2013
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)